NCT03961386

Brief Summary

This randomized-control trial involves dyads consisting of a family caregiver (CG) and a person with memory loss or dementia (PwD). The FallsTalk Caregiver Resource System (FT-C) intervention is administered by the CG, whose role is to modify their interactions with the PwD. FT-C will create a 3-way partnership between an Interventionist and the dyad, capitalizing on CG-PwD interactions. The PwD will be observed by the CG and both will be evaluated by the study team. Brief daily FT-C intervention by the CG will stimulate the PwD's awareness and individualized weekly CG- check-ins with the Interventionist will increase the CG's skills. Our hypothesis is that FT-C will increase PwD's awareness of personal fall threats and encourage new falls prevention behaviors, resulting in reduced fall rates.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

9 months

First QC Date

May 22, 2019

Last Update Submit

June 4, 2019

Conditions

Falls (Accidents) in Old Age

Keywords

prevention

Outcome Measures

Primary Outcomes (2)

  • Rate of falls

    number of falls per month

    weekly for up to one year

  • Change of Residence

    Report of change of primary residence

    weekly for up to one year

Secondary Outcomes (4)

  • Fall Threat Awareness

    Pre-test- 5 clips at Initial interview; Post-test- 5 clips at Follow-up interview one month later

  • Activity-Specific Balance Confidence scale

    Pre-test at Initial interview; Post-test at Follow-up interview one month later

  • Caregiver Falls Prevention Concerns

    Survey administered at study entry and Follow-up visit.

  • Burden Scale for Family Caregivers

    BSFC is administered at Initial interview and Follow-up interview one month later.

Study Arms (3)

FallsTalk-C

EXPERIMENTAL

FallsTalk CG intervention

Behavioral: FallsTalk-CBehavioral: FallsTalk

FallsTalk

ACTIVE COMPARATOR

FallsTalk intervention

Behavioral: FallsTalk

PostCardOnly

NO INTERVENTION

Postcard only- Control group

Interventions

FallsTalk-CBEHAVIORAL

The FT-C experimental intervention involves two face-to-face visits including Initial and Follow-up Interviews, CG training, daily interaction with the PwD using a computer with FT-C software, weekly check-in calls, weekly postcard completion and monthly check-in calls for at least six months and up to one year.

FallsTalk-C
FallsTalkBEHAVIORAL

The FallsTalk intervention involves two face-to-face visits including Initial and Follow-up Interviews,CG training, daily interaction with the PwD, weekly check-in calls, weekly postcard completion and monthly check-in calls for at least six months and up to one year.

Also known as: Attentional control- the same number of steps and an equivalent amount of time is devoted to these participants.
FallsTalkFallsTalk-C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • residence in western Washington state
  • minimum age= 18
  • family CG
  • primary CG
  • some daily personal contact with Person with Dementia (PwD) for 1 month
  • basic computer skills and telephone access
  • able to commit to 6 month study.
  • living at home with residence in western Washington state
  • minimum age= 55
  • at least one fall in last 6 months or regular loss of balance
  • can ambulate at least 6 feet
  • ability to communicate thoughts
  • willingness to participate.

You may not qualify if:

  • Professional CG (unless primary CG for family member)
  • distance CG unable to be physically present with PwD daily for 1 month
  • terminal illness with less than 6 months to live
  • CG has significant memory loss.
  • Residence outside of western Washington state
  • Living in Residential care setting
  • non-communicative
  • terminal illness with less than 6 months to live
  • wheel chair or bed bound.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brookside Research & Development

Freeland, Washington, 98249, United States

RECRUITING

Study Officials

  • Victoria Panzer, PhD

    Brookside Research & Development

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brookside R&D

CONTACT

206-317-3173Info@FallScape.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 23, 2019

Study Start

March 13, 2019

Primary Completion

December 1, 2019

Study Completion

May 1, 2020

Last Updated

June 6, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)